The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol Levels in Patients With Metabolic Syndrome

• Sponsor: Universiteit Antwerpen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02065180
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 2.9
• Patients Per Site Per Month: 17.1

Study Details

Study Description

Brief Summary

This randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolaemia	Dietary Supplement: commercially available nutrition supplement; Dietary Supplement: placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of a Red Rice and Olive Extract Nutrition Supplement on Cholesterol
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: commercially available nutrition supplement this group receives a commercially available nutritional supplement for a period of 2 months	Dietary Supplement: commercially available nutrition supplement; the food supplement contains red rice yeast and olive extract
Placebo Comparator: control group this group receives a placebo for a period of 2 months	Dietary Supplement: placebo

Outcome Measures

Primary Outcome Measures

1. LDL level [2 months]

2. total cholesterol level [2 months]

3. triglyceride level [2 months]

4. HDL level [2 months]

Secondary Outcome Measures

1. OxLDL [2 months]

2. BMI [2 months]

3. malondialdehyde (MDA) [2 months]

4. 8-OH-deoxyguanosine (8-OHdG) [2 months]

5. side effects [2 months]

6. waist circumference [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• metabolic syndrome according to ATPIII criteria 3 of the following:

• waist circumference >88cm (in females) or >102cm (in males)

• triglycerides >150mg/dl

• HDL <40 (50)mg/dl in males (females)

• blood pressure>130/85 or treatment for AHT

• glucose >110mg/dl

Exclusion Criteria:

• pregnancy

• treatment with cholesterol lowering drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Antwerp	Antwerp	Belgie	Belgium	2610

Sponsors and Collaborators

• Universiteit Antwerpen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Veronique Verhoeven, Professor, Universiteit Antwerpen
• ClinicalTrials.gov Identifier: NCT02065180
• Other Study ID Numbers: verhoevenhermans
• First Posted: Feb 17, 2014
• Last Update Posted: May 20, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Hypercholesterolemia

Study Results

No Results Posted as of May 20, 2014